Sanofi/Teva Unveil New Detailed Data For Duvakitug Study Supporting Overall Efficacy For Common Inflammatory Bowel Disease

On Saturday, Teva Pharmaceuticals Industries Ltd. TEVA and Sanofi SA SNY presented new, detailed results from the RELIEVE UCCD Phase 2b study of duvakitug (TEV’574/SAR447189) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD), the two most common forms of inflammatory bowel disease (IBD).

These results were shared at the Congress of the European Crohn’s and Colitis Organisation.

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Ulcerative colitis

• In the UC cohort of the RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of clinical remission (mMS) at week 14 compared to 20% treated with placebo.
• Placebo-adjusted rates were 16% (450 mg) and 27% (900 mg) (p=0.050 and 0.003, respectively).
  • Higher clinical remission rates were observed for both doses of duvakitug versus placebo in both advanced therapy (AT)-experienced and AT-naïve subgroups of patients.AT-experienced: 29% (450 mg) and 36% (900 mg), with placebo-adjusted rates of 22% (450 mg) and 29% (900 mg).
  • AT-naïve: 39% (450 mg) and 53% (900 mg), with placebo-adjusted rates of 12% (450 mg) and 26% (900 mg).1-3

Crohn’s disease

• In the CD cohort of the RELIEVE UCCD study, 26% (450 mg) and 48% (900 mg) of patients with CD treated with duvakitug achieved the primary endpoint of endoscopic response (SES-CD) compared to 13% on placebo.
• Placebo-adjusted rates were 13% (450 mg) and 35% (900 mg) at week 14 (p=0.058 and <0.001, respectively).
  • Higher endoscopic response rates were observed for both doses of duvakitug versus placebo in both AT-experienced and -naïve subgroups of patients.AT-experienced: 11% (450 mg) and 48% (900 mg), with placebo-adjusted rates of 7% (450 mg) and 44% (900 mg).
  • AT-naïve: 47% (450 mg) and 47% (900 mg), with placebo-adjusted rates of 25% (450 mg) and 25% (900 mg).

The company expects to start the Phase 3 program in the second half of 2025.

Price Action: TEVA stock is down 0.18% at $16.70, and SNY stock is down 0.48% at $54.20 during the premarket session on last check Monday.

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